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临床试验/NCT01250912
NCT01250912已完成不适用

Three Dimension Neuron Imaging Using 123I-metaiodobenzylguanidine Single Photon Emission Computed Tomography to Guide Ventricular Tachycardia Ablations

University of Maryland, Baltimore1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline

研究概览

简要总结

Some patients are at risk for life-threatening fast heart rates. These can frequently be treated by using a catheter inside the heart to burn away the cells that create the fast heart rates. The purpose of this study is to image the nerves inside the heart of those patients. The investigators want to find out if abnormalities in the nervous system in the heart can help the physician to find the area that needs to be burnt away.

详细描述

Ventricular tachycardia is the next frontier in cardiology. Patients that have scar in the heart (for example after heart attacks) are at an increased risk of developing ventricular tachycardia. In these patients ventricular tachycardia represents an electrical wave front that circulates in the heart muscle using the scar in the heart. An increasing number of patients with ventricular tachycardia require cauterization (burning away) of the tissue to treat this life-threatening condition. The goal of this cauterization or ablation is to destroy "highways of surviving tissue" inside the scar, that allow ventricular tachycardia to exist. However, this can be very lengthy procedure (>5 hours) that has only a moderate success in the long run. Therefore, new treatment approaches are needed to make this procedure better.

The purpose of this study is to assess if radio tracers showing the nerve distribution in the heart (cardiac innervation) can be used in addition to the current technology ("voltage mapping") to identify the area that needs to be ablated (burnt away) to treat life-threatening fast heart rates (ventricular tachycardia)

Certain patterns of nerve distribution in the heart (sympathetic cardiac innervation) have been shown to predict outcome for different heart diseases, like heart transplant, coronary artery disease, heart failure, arrhythmias. One substance that allows visualization of the cardiac innervation is 123I-metaiodobenzylguanidine (123I-MIBG), which could provide additional information to understand and treat ventricular tachycardia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with ventricular arrhythmias requiring VT Ablation
  • Patients must be 18 years of age or older
  • Patient must be able to sign consent form
  • Patient must be willing to come back for the 6 month visit for additional study procedures

排除标准

  • Patient under 18 years old
  • Inability to sign consent
  • Pregnant Women

研究组 & 干预措施

Imaging Tracer

Experimental

No arms, the Radio tracer will be used in all subjects imaging tests.

干预措施: 123I-metaiodobenzylguanidine (Drug)

结局指标

主要结局

Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline

时间窗: Baseline

Scar Measurement on both MIBG 3D map and electroanatomic scare defined as bipolar voltage \<0.5mV using Standard 17-segment American Heart Association areas.

次要结局

  • Median Segmental MIBG Uptake at Baseline(Baseline)
  • Median Segmental MIBG Uptake at 6 Months After Ablation(6 months after ablation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Timm-Michael Dickfeld

Professor of Medicine

University of Maryland, Baltimore

研究点 (1)

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